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Disarticulation Septoplasty Versus Classical Way

— Observational Nasal Septum Deviation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice.
Who it may be relevant to
Registry conditions: Nasal Septum Deviation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study

Overview

The objective of this study is to determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results for correcting symptomatic deviations of the nasal septum. More specifically it's about: * Compare the improvement in respiratory symptoms between the two techniques * Analyze and compare complication rates between the two techniques * Evaluate patient satisfaction with aesthetic results (including columella deviation)

Detailed description

Nowadays, disarticulation septoplasty is recognized as an effective technique for correcting complex septal deviations. It allows better exposure of the nasal septum, which facilitates the correction of severe deformities and reduces post-operative complications. This method is often compared to open surgery, which remains a classic approach but perhaps less suited to cases of severe or complex deviations. This technique makes it possible to correct aesthetic deviations while improving the functional aspect avoiding an open path.

There are several questionnaires, particularly in the field of rhinology, to evaluate the results of this technique on nasal obstruction in an objective and subjective manner, therefore its impact on quality of life as well as its effectiveness on chronic nasal dysfunction caused by deviation of the nasal septum. In this study, in addition to nasal symptoms before and after surgery and postoperative complications, we chose to work with two scores; NOSE score as a valid, reliable and responsive self-report instrument to quantify subjective dysfunction related to nasal obstruction. The other score is NAFEQ score which makes it possible to evaluate the aesthetic and functional outcome after nasal reconstruction.

Interventions

  • Other Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
    Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice

Primary outcome measures

  • To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations [Time frame: Before and at least 3 months after the operation]
Secondary outcome measures (4)
  • Compare the functional improvement between the two techniques, using a different tool [Time frame: Before and at least 3 months after the operation]
  • Compare the improvement in respiratory symptoms between the two techniques [Time frame: Before and at least 3 months after the operation]
  • Analyze and compare the complication rates between the two techniques [Time frame: At day 15 and 3 months after the operation]
  • Assess patient satisfaction with aesthetic results (including columellar deviation) [Time frame: Before and at least 3 months after the operation]

Eligibility criteria

Inclusion criteria

  • Patient aged 18 and over
  • Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
  • Patient operated between 01/01/2023 and 31/12/2025

Exclusion criteria

Patient undergoing surgery but with the following medical history (on the day of surgery):

  • Patient with septal perforations
  • Patient with previous nasal septum surgery or cosmetic rhinoplasty
  • Patient with allergic rhinitis
  • Patient with chronic sinusitis
  • Patient with concha bullosa
  • Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hopital Novo — Pontoise

Publications

  • Jankowski R, Gallet P, Nguyen DT, Rumeau C. Septoplasty by disarticulation. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Nov;137(5):423-426. doi: 10.1016/j.anorl.2020.07.014. Epub 2020 Oct 2. PMID 33020044

Identifiers

NCT: NCT07412340 · CHRD 1925

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗